Migraine and obesity

New Post Hoc Phase 3 Data Analysis Shows AJOVY® (fremanezumab) Reduced Migraine Attacks in Adults with Migraine and Co-morbid Obesity

  • AJOVY® (fremanezumab) efficacy and safety demonstrated in migraine patients with obesity in post hoc analysis of HALO-LTS[i] and FOCUS[ii] Phase 3 studies
  • Obesity is a known risk factor for migraine and is frequently associated with an increase in migraine frequency, severity and disability[iii]
  • Data revealed at the 17th European Headache Congress, Barcelona, Spain

6th December, 2023: Teva Pharmaceuticals has announced that a post hoc analysis [iv] of two Phase 3 clinical studies presented at the European Headache Congress has shown the effectiveness of the migraine prevention treatment AJOVY® (fremanezumab) in reducing migraine attacks in patients with migraine and co-morbid obesity.

Migraine and obesity are both associated with high levels of disability.3 The 2021 Health Survey for England5 estimates that 25.9% of adults in England are obese and a further 37.9% are overweight, with people aged 45-74 most likely to be overweight or obese. In Europe, it is estimated that 59% of people are either overweight or obese, with almost a quarter (23%) of adults living with obesity.6

A higher body mass index (BMI) is frequently associated with increased migraine prevalence and severity, and an increased number of adverse effects.3 As such, assessing the efficacy and safety of migraine preventative treatment in patients with obesity can help guide migraine management and treatment decisions.

The post hoc analysis of the HALO-LTS1 and FOCUS 2 Phase 3 studies compared the safety and efficacy of fremanezumab migraine preventive treatment in obese migraine patients versus normal weight migraine patients for a period of six months. Obesity was defined as having a Body Mass Index (BMI) ≥30 kg/m2 (BMI-high, 578 patients), and normal weight patients with a BMI <30 kg/m2 (BMI-normal, 1859 patients).

[Read ACNR headache articles]

The analysis showed that the efficacy of fremanezumab was the same in migraine patients with BMI-high vs BMI-normal:

  • At baseline, monthly migraine days in migraine patients with BMI-high vs BMI-normal were 13.7 vs 13.6 respectively
  • After 6 months of treatment with fremanezumab, monthly migraine days in migraine patients with BMI-high vs BMI-normal was reduced to 6.8 vs 7.2 respectively

Furthermore, adverse events (AEs) in patients with obesity were similar to AEs in non-obese patients treated with fremanezumab.

This analysis is encouraging as it shows fremanezumab can reduce migraine attacks as effectively in obese patients as it does in patients of normal weight. Considering the higher burden of migraine in patients with co-morbid obesity, it is important for treatments to demonstrate efficacy and safety in migraine patients with this particular comorbidity.

Lead study author, Consultant Neurologist Dr Pablo Irimia Sieira, of Clinica Universidad de Navarra, Pamplona, Spain

AJOVY® (fremanezumab), a humanised monoclonal antibody (mAb) developed by Teva Pharmaceuticals, selectively targets the calcitonin gene-related peptide (CGRP) and is approved for the prevention of migraine in adults who have at least four migraine days per month.


[i] HALO-LTS, NCT02638103

[ii] FOCUS study NCT03308968

[iii] Westgate CSJ, et al. Understanding the link between obesity and headache- with focus on migraine and idiopathic intracranial hypertension. J Headache Pain. 2021;22(1):123.

[iv] Sieria Pablo, et al. Efficacy and Safety of Fremanezumab in Patients with Migraine and Obseity: Post Hoc Analysis of the Phase 3 HALO-LTS and FOCUS Clinical Trails. Presented at the European Headache Congress December 2023. PO35 Poster

5 UK Parliament House of Commons Library. Obesity Data. Available at: https://commonslibrary.parliament.uk/research-briefings/sn03336/#:~:text=Adult%20obesity%20in%20England,is%20classified%20as%20’overweight Accessed: Nov 2023

6 WHO Regional European Obesity Report 2022